CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report

The Endomag Magseed Pro Magnetic Marker System is a sterile recalled

Endomagnetics is recalling The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed, distributed nationwide in the US. The recall was initiated on 1 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. MS2-17-1-12. GTIN:15060391210466. UDI: 15060391210466250327-01, 15060391210466250415-07, 15060391210466250523-10, 15060391210466250612-50. Batch Number: 250327-01, 250415-07, 250523-10, 250612-50.

Quantity recalled540 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0317-2026
FDA event ID: 97680
Recalling firm: Endomagnetics, Cambridge, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 1 Oct 2025
FDA classified: 24 Oct 2025
Reported: 5 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

1 Oct 2025	Recall initiated by company
24 Oct 2025	Classified by FDA	+23 days
5 Nov 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for contamination with cotton fibers.

Product as listed by the FDA

Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Where it was distributed

Worldwide - US Nationwide distribution in the states of CA, CO, CT, DC, FL, GA, IA, ID, IN, KY, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, TX, WA and the country of Canada.

Nationwide California Colorado Connecticut District of Columbia Florida Georgia Iowa Idaho Indiana Kentucky Maryland Maine Michigan Minnesota Missouri North Carolina North Dakota Nebraska New Hampshire New Jersey

Questions about this recall

Why was it recalled?

Potential for contamination with cotton fibers.

Which lots are affected?

Model No. MS2-17-1-12. GTIN:15060391210466. UDI: 15060391210466250327-01, 15060391210466250415-07, 15060391210466250523-10, 15060391210466250612-50. Batch Number: 250327-01, 250415-07, 250523-10, 250612-50.

Where was it sold?

Worldwide - US Nationwide distribution in the states of CA, CO, CT, DC, FL, GA, IA, ID, IN, KY, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, TX, WA and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97680

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025	CLASS II	The Endomag Magseed Pro Magnetic Marker System is a sterile recalled	Endomagnetics	Other	Nationwide

More recalls from Endomagnetics

All 2

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Device	CLASS II	The Endomag Magseed Pro Magnetic Marker System is a sterile recalled	Endomagnetics	Other	Nationwide

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